There is no room for error. Or imperfections, for that matter.

As a tooling manager/CNC programmer and manufacturing engineering professional, David Gwaltney has abided by this mantra throughout his three decade-plus career. He fully understands the level of precision and sophistication needed to create a medical mold or tool, and is equally aware of the tight tolerances and razor-like accuracy involved in manufacturing small medical components.

“Shutoffs have to be extremely tight and venting is extremely important,” noted Gwaltney, a tool and die manager at Brecksville, Ohio-based Applied Medical Technology Inc. (AMT). “We try to do absolutely zero hand fitting or polishing on tooling because we just can’t live with the tolerances of hand work compared to what comes off of a machine.”

AMT develops, designs, and manufactures enteral feeding devices, accessories, and surgical products. For most of its existence, the company had farmed out its manufacturing to third-party contractors but that system had started to yield less-than-desirable results.

“Looking at the tools and how they were built, we started seeing a pattern of problems,” Gwaltney explained in a an online case study. “It was close, it left us with a lot of secondary opMerations, which means additional labor.”

Additional labor, of course, begets additional costs. And additional costs can undercut profitability.

Between the problems AMT was experiencing with its third-party manufacturers, the expenses associated with flawed tools, and the challenges of managing both logistics and third-party vendors, AMT management ultimately opted in early 2017 to bring its mold manufacturing operations in-house.

In assessing the firm’s manufacturing needs, Gwaltney extensively researched the capabilities and equipment used by other device manufacturers and tool builders. He scrutinized facility lists, met with co-workers, and discussed shop floor operations with tool producers.

There was one common thread amid all that research: Yasda brand machines. Made by Satosho, Japan-headquartered Yasda Precision Tools K.K., the machining centers boast a 0.001 mm accuracy and are used to produce parts for the automotive, aerospace, medical equipment, semiconductor, and smartphone industries.

Upon witnessing the capabilities of Yasda machine centers while touring several machine tool builder factories in the United States and abroad, Gwaltney and AMT executives decided to outfit the company with the Yasda YMC 430, a high-end five-axis machine tool designed to meet the increasing demand for ultra-high precision, high quality micro machining.

The YMC 430 features a 40,000 min-1 spindle that provides stable and high-precision machining for longer periods of time irrespective of the tool type or rotation speed. The machine also has an automatic tool changer (ATC) with the standard 32 tools, but that total can be expanded to 90 tools. The 90-tool ATC requires the same installation space as the standard 32-tool ATC, according to Yasda.

Yasda’s high-precision machines enabled AMT to end its reliance on third-party manufacturers, increase throughput, and achieve tighter tolerances.

“The accuracy of it is just amazing,” Gwaltney stated. “Some of our cavity work is so small, we rough and finish all at the same time, you can hold most of our blocks in your hand. It’s definitely opened up a lot of opportunities. Our products are much better, our tolerances are better, and our tooling holds up better just because it starts of in a better place than it did before.”

AMT’s quest for machining magnificence exemplifies the indispensable role CNC and other machining technologies play in producing highly accurate, efficient, and reliable medical components. CNC machines can perform a wide range of machining operations, including milling, turning, drilling, grinding, cutting and engraving, generating implants customized to a patient’s anatomy and miniature parts that are not visible to the naked eye without magnification.

To further explore the wonders (and challenges) of modern medical machining, MPO spoke to nearly a half-dozen experts over the summer. Input came from:

• John Cross, director of Advanced Machining at MICRO, a Somerset, N.J.-based full-service contract manufacturer of precision medical and surgical components, subassemblies, complete devices, and finished class-critical implant devices.
• Reed Hannegraf, operations and engineering manager at Mountain Manufacturing Technologies, a leader in precision machining of specialty wire and metal tubing headquartered in Lino Lakes, Minn.
• Timothy Kimball, pacing operations manager at Cretex Medical, a contract manufacturing and engineering services provider based in Elk River, Minn.
• Dean J. Tulumaris, president/CEO of Anjon Medical Technologies, a contract manufacturer of implants, components, and finished medical devices. The Jacksonville, Fla.-headquartered firm also offers design assistance and sterilization/packaging/validation services.
• Zane Wyatt, NPI engineering manager at Medical Device Components LLC, a precision machining component provider. The company was part of Johnson Matthey plc until its divestment this past July to Montagu Private Equity.

Michael Barbella: Please discuss the industry trends and challenges currently impacting medical device machining. Have these trends and challenges changed in recent years?

John Cross: The medical device manufacturing field is constantly advancing technologically. We’ve had to remain agile to stay ahead of the curve, a principle that’s been core to MICRO since we were founded nearly 80 years ago. The shareholders of the company place a premium on reinvesting in technology and adding more services internally to control quality, cost, and delivery. The recent experience of the COVID-19 pandemic reinforced the value of controlling as much of the supply chain under one roof as possible.

Reed Hannegraf: With the current trend of components/products made from superalloys, materials being of high concentrations of titanium, nickel, cobalt, chromium, molybdenum complemented by various required material conditions. Challenges of processing these material types are continually changing and evolving within the industry.

Locating/recruiting personnel that are technical-minded with the experience and knowledge of staying on the forefront of material types and conditions with the insight of processing techniques is a challenge that will not go away any time soon for teams providing these high-end technical solutions covered across the precision machining and manufacturing spaces.

Timothy Kimball: Uncertainty is a significant challenge impacting manufacturers in the medical device field. Even groundbreaking technologies can falter if pricing exceeds what the market can sustain, especially in niche segments such as rare conditions. Understanding market dynamics and potential adoption rates is inherently unpredictable. All this makes agility in scaling operations to meet demand fluctuations more important. Incorporating design for manufacturability (DFM) principles early in the development process minimizes risks, optimizes production efficiency, and ensures the delivery of superior devices.

Globalization presents both opportunities and challenges, and the industry’s approach to it has evolved. Factors like supply chain resilience and quality control are driving demand for U.S. production. MDMs need to balance global outreach with local production capabilities. As the market evolves, manufacturers who excel at innovation, strategic cost management, and speed-to-market are best positioned to succeed.

Dean Tulumaris: The trend is micro. Increasingly, implantable items are being designed so they can be utilized in non-invasive surgeries. The trend has been for several years toward non-invasive procedures. For example, with a non-invasive procedure, the process uses a guidewire/delivery system that goes up the femoral artery or through the arm, for implanting a device in the body. A good example of this is a stent and a heart valve, which can be placed as required utilizing this non-invasive procedure.

When designing an implantable component, engineers are designing them with tighter tolerances and thinking miniature or micro. Thus, when machining, you must have machines that can cut and hold very tight tolerances and dimensions. In most cases, these products require a 5-axis CNC so you can meet the products’ tight tolerances, design requirements, and dimensions.

Zane Wyatt: As technology continues to evolve, customers are looking for more complex components to increase the capability of their devices. Due to the inherent size constraints that exist working within the human body, instead of simply expanding the size of their devices and components to introduce more capability, medtech OEMs are being more creative to push manufacturing limits and fit more capability within existing size envelopes.

What this translates to from a design standpoint is smaller feature sizes, higher aspect ratios, tighter tolerances, more complex shapes, and sometimes specialized coatings on components to achieve specific performance characteristics.

We’ve also witnessed a trend toward laser processing where many components we see are only possible to produce via laser. MDC has invested in the latest laser micromachining technology, deploying Femtosecond laser sources to produce burr-free features and integrated precession scanning modules for advanced beam control, allowing for high aspect-ratio holes with no wall taper. We’ve also onboarded laser-turning and laser-ablation technologies, which can produce complex blind geometries as well as mimic a traditional Swiss turning operation using a laser beam.

Barbella: What are customers looking for in machining solutions/services?

Hannegraf: The quick delivery of developing precision components made from a vast variety of materials that meet or exceed design expectations related to key performance.
Engineering support and DFM feedback affects scalability to market, maintained supply streams, and cost of end products.

Dedicated solutions teams are needed that have the ability to support aggressive build timelines, product design changes, hurdles related to raw material supply chains, and real time answers without impacting delivery schedules.

Kimball: Today’s customers are looking for more than just a black box solution. They expect a partnership with real-time information, continuous feedback loops, and a commitment to serving patient needs at every stage. An MDM should be able to offer valuable insights and solutions before the customer even asks. This proactive approach extends beyond mere product delivery; it encompasses understanding and anticipating the broader needs of customers and end-users alike. Every MDM can claim to offer technical skill. It’s imperative for manufacturers to go the extra mile by fostering collaborative relationships built on transparency, foresight, and a shared commitment to patients.

Tulumaris: Customers are always looking for exceptional quality, prompt delivery, and great pricing. Suppliers who can not only make the component but can also offer the secondary operations, (so that the product or components are fully complete and/or assembled) is primarily what customers are looking for. They are also looking for assistance and guidance in the product development and product design for manufacturability. Lastly, in some cases, they are looking for aid with regulatory and quality information/inspection/documentation. In today’s market, customers prefer a full-service partner.

Wyatt: Customers are looking for a partner to collaborate closely with during the initial R&D phase all the way through production launch. They expect proactive DFM discussions to lower the cost and complexity of the components while maintaining design intent. Flexibility and speed are essential during the R&D stage; this includes enabling last-minute modifications and providing prototypes with several design iterations in a compressed time. Customers also expect their machining suppliers to be on the cutting edge of technology to support the increased complexity of their components, in some cases co-developing technology with them to achieve success. MDC embraces close customer collaboration by involving several team members from our engineering, NPI, and commercial teams to contribute to mutual holistic success.

One recent successful example of this was in the launch of six complex micro-components used on a next-generation electrophysiology catheter: members of the MDC engineering and commercial teams traveled to the customer’s site one to two times per week for over a year to have direct collaboration with the catheter OEM’s R&D team. We collaborated on multiple design iterations, while also iterating on prototype configurations using a dedicated CNC machine to finalize these complex component designs. MDC successfully introduced these six micro-components through validations and into high-volume worldwide production today.

Barbella: In what ways are advancements in automation, materials, digital technology, and additive manufacturing driving innovation in CNC machining (and/or laser processing equipment)?

Cross: Our arsenal includes multiple multi-axis machining centers, Willemin 408MT machines, and Citizen Swiss Turning centers with integrated laser cutting, which we call “Laser Swiss.” This diverse range of capabilities allows us to achieve unprecedented precision and complexity in our components. The integration of these advanced manufacturing technologies has opened new possibilities for MICRO. Our “Laser Swiss” capabilities combine the precision of Swiss turning with the flexibility of laser cutting, enabling us to produce intricate parts that were previously impossible or impractical to manufacture. Additionally, our multi-axis machining centers provide us with the versatility to handle a wide range of complex geometries required in minimally invasive surgical devices.

Automation has become a key focus for MICRO, addressing both efficiency and the skilled labor shortage. We’re investing heavily in automation throughout our production process. This not only improves our productivity and consistency but also allows us to redeploy our skilled workforce to more complex, value-added tasks.

Hannegraf: All are having a significant impact on precision machining, from robotics, large integrated palletized part systems, stored statistical process controls that reinforce specifications needed to produce large volumes of components that will meet customer requirements with low associated risk platforms.

Kimball: Automation is driving significant improvements in the CNC space. By removing burdensome and repetitive work from employees, we can engage their skills more safely and effectively so they can take on more tasks. This generates more employee satisfaction, increases production, and minimizes costs.

Overprocessing is always a risk in manufacturing. We can mitigate that by employing data-driven technologies to ensure efficiency and repeatability.

Tulumaris: 3D printing/additive manufacturing is enabling companies to create custom components in various industries including medical, dental, and automotive. With 3D, components and parts can be made lighter, stronger, and more durable. Another advantage is that 3D is much quicker than a conventional manufacturing in most cases. As it continues to develop, more companies and industry will be using this technology.

Wyatt: The technology for automation has progressed rapidly to the point where multi-axis, pick-and-place robots are much less expensive and are simpler to integrate. MDC has invested in robotic pick-and-place automation in our laser CNC machines as well as our automated inspection equipment. For our tube-cutting laser CNC machines, MDC has integrated an automated bar feeder which has been heavily customized to automatically load fragile tubes down to 0.010in [0.254mm] diameter.

MDC has been investing in the latest digital technology for quite some time now, used commonly in inspection and data capture/analysis. With recent technological advances, we’ve been able to link into any CNC machine and output dozens of variables real-time to analyze and trend over time.

ALM [additive manufacturing process] advancements have had a major impact on the industry. Plastic printers are so inexpensive now that most companies have multiple printers available to them for several applications with the most popular being permanent tooling or going through quick test iterations of tooling prior to investing in metal. Due to the extremely small size of our typical components (the average size being the tip of a pen), a popular use at MDC is to print scaled-up models of our micro-components to better visualize during meetings, troubleshooting, etc. Metal printing has also advanced significantly and while MDC does not currently own a metal printer, we frequently order printed metal components for tooling designs that would otherwise not be possible to machine.

Barbella: In what ways can CNC machines or laser processing equipment be improved to address the medtech industry’s ever-evolving needs?

Hannegraf: Machine accuracies, spindle speeds, tooling capacities, automated loading and unloading of either raw material or finished components must continue to expand on and evolve to support the growth that the medtech industries are providing. A key takeaway will be the expansion of multi-tasking equipment with integrated platforms to provide finished components within a single operation.

Tulumaris: CNC machines and lasers are being designed and built so they can make new and unique designs with tighter tolerances, dimensions, and micro componentry. Also, they are also able to cut numerous types of materials such as polymers, titanium, nitinol, and stainless steel, to name a few. Lastly, they possess the ability to machine different finishes that are required for secondary operations.

Wyatt: One significant improvement opportunity with laser processing is further integration with other CNC technology. There are companies out there with hybrid systems incorporating Swiss and Laser capability in a single machine, however this is generally a compromised machine as either the Swiss capability or laser capability is limited to support the integration. A perfect CNC machine to meet the shrinking demands of medtech micro-components would include full Swiss machining capability and femtosecond laser with a precession module to fully integrate both in a single machine setup.

Barbella: Is augmented reality playing a role in medical device machining? If so, how?

Kimball: We find augmented reality (AR) very helpful in remote maintenance and support, particularly when working with suppliers in other countries. Using AR, we can work through repair and maintenance in real time, drastically reducing downtime and travel costs. 

In the long run, we see more and more use of AR in end-user training. For example, surgeons can become expert in new technologies using AR long before they need to use that technology with a live patient.

Wyatt: The primary application we have seen for augmented reality in medical device machining is related to machine repair/maintenance. If programmed correctly, the maintenance technician can use augmented reality glasses and get real-time information and instructions based on the area of the machine they are looking at. Hypothetically this type of technology could be expanded to a production line, however, the technology is still quite in its early stages and very challenging to implement effectively.

Barbella: What trends in machining will you be following in the near and/or long term that will become more important and/or have a significant impact on the medical device industry?

Hannegraf: Training and advancements of what was once considered a machinist by title but has transformed into a very advanced technical resource that must be able to support evolving metallurgy knowledge, machining fundamentals, technical advances in sophistically engineered equipment of both manufacturing and metrology applications, software programming, and process development related to additive manufacturing and beyond.

Kimball: As the industry evolves, we expect there to be less and less emphasis on incremental improvements in medical devices. Instead, manufacturers will emphasize the ability to bring together various technologies to provide a suite of solutions. In that environment, MDMs who can successfully leverage multiple cutting-edge tools, while delivering on manufacturing fundamentals, will succeed.

Tulumaris: 3D printing, micro machining, and coatings. Device manufacturers are designing their products to be coated or finished after machining. This also includes drug coatings that are applied to their components or product before implantation. An example of this is drug-eluting stents. The other significant trend is micro componentry with the evolution of non-invasive procedures. Smaller and effective is better. 3D printing is advancing where you can make products faster, stronger, and more durable.

Wyatt: While ALM has advanced significantly, it still is not capable of printing components at the size and tolerance scale of the micro-components demanded by the medtech industry. ALM of micro-machined components from both base metals and precious metals would be highly disruptive to the industry and MDC will be actively investing and researching in this space to stay ahead of the curve.

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